Biotech | January 22, 2022
Pfizer and OPKO update on the Biologics License Application for Somatrogon
Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward
Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward
An article by a team of 12 Italian and 9 Russian scientists led by Francesco Vaia, Director of the Spallanzani Institute and Alexander Gintsburg, Director of the Gamaleya Center, has been published in medRxiv
Four-year research collaboration combines Pfizer’s deep experience in global drug development, including programs utilizing messenger RNA (mRNA), lipid nanoparticles (LNP), and gene therapy, with Beam’s leadership in base editing and mRNA/LNP delivery technologies
Product candidates will be based on BioNTech’s proprietary mRNA technology and on Pfizer’s antigen technology. Clinical trials are expected to start in the second half of 2022
First emergency use authorization in the United States for a Covid-19 vaccine booster in adolescents 12 through 15 years of age
Pfizer raises production projections from 80 million to 120 million courses of treatment in 2022, as a result of continued investments to support the manufacturing and distribution of Paxlovid
EMA’s CHMP advice states that Paxlovid can be used for treatment of adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease
The data has been shared with the U.S.FDA as part of an ongoing rolling submission for Emergency Use Authorisation
The proposed acquisition offers a potentially new, differentiated best-in-class approach to address the unmet need for a broader number of patients with immuno-inflammatory diseases
According to the companies’ preliminary data, a third dose provides a similar level of neutralizing antibodies to Omicron as is observed after two doses against wild-type and other variants that emerged before Omicron
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